Transseptal Puncture Apparatus

ABSTRACT

Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. Ser. No.60/517,983, filed Nov. 6, 2003, the contents of which are incorporatedby reference herein.

FIELD OF THE INVENTION

The invention generally relates to a device for performing anintracardiac transeptal puncture procedure. More specifically, thedevice relates to transeptal puncture of the atrial septum for thetreatment of intracardiac defects such as patent foramen ovale (PFO) andother therapeutic applications for diseases associated with the heart.

BACKGROUND OF THE INVENTION

Septal puncture is utilized in patients in which a communication ispresent between the two atria of the heart, for example, a patient witha patent foramen ovale (PFO). A PFO consists of two layers ofoverlapping but unfused tissues, the septum primum and the septumsecundum, forming a tunnel like “hole” between the two tissues that canput the patient at a high risk of embolic stroke. Due to the tunnel-likenature of many PFOs, an occlusion device that is used to repair the PFOoften does not sit flat on the septal wall when it is implanted, suchthat a portion of the occluder is positioned in the PFO tunnel. For thisreason a second hole in the septum primum part of the atrial septum nearthe PFO is introduced by septal puncture through which the occlusiondevice is the positioned (rather than through the PFO tunnel).

Septal puncture through an intact atrial septum from the right atrium tothe left atrium is also often necessary. This is traditionally performedusing rigid, long needles, such as Brockenbrough or Ross needles. In alltypes of septal puncture, the needle that is used to puncture the atrialseptum poses a high risk of inadvertent puncture through tissue otherthan the septum primum, for example, the atrial free wall, posing asignificant risk to the patient. For PFO closure, this risk ispotentially even higher, due to the fact that the septal tissue isdefective and often thinning, and may stretch an even greater amountduring the puncture procedure, bringing the tip of the needledangerously close to the atrial free wall or the left atrial appendage.

A device and method that permits the surgeon to safely puncture both anintact atrial septum and an atrial septum having a PFO is thereforeneeded.

SUMMARY OF THE INVENTION

The invention relates generally to devices and methods for performing atranseptal puncture procedure that are safe alternatives to thosecurrently being performed.

In one aspect, the invention relates to a device for puncturing theatrial septum of a patient. In one embodiment of the invention, thedevice includes a first, outer needle with a blunt distal end and alumen longitudinally disposed therethrough and a second, inner needleaxially disposed in the lumen of the outer needle. In an embodiment, theinner needle has a proximal portion, an intermediate portion, and adistal portion, wherein the intermediate portion is more flexible thaneither the proximal portion or the distal portion of the inner needle.

In an embodiment, the intermediate portion is a segment that isapproximately 20 mm from the distal end of the inner needle. Theintermediate portion may be, for example, 3 mm in length. In anembodiment, the intermediate portion has a waist. The waist of theintermediate portion is, for example, about 0.2 mm in diameter. In aparticular embodiment, the intermediate portion of the inner needle maybe made of a polymer.

In another embodiment, the inner needle has a distal portion and aproximal portion, wherein the distal portion is more flexible than theproximal portion. In another embodiment, the inner needle is flexible inboth the distal portion and the proximal portion (e.g., has homogeneousflexibility).

As another feature, the distal portion of the inner needle has a distalportion that deviates from the linear path of the inner needle such as,for example, a taper, a bend, a curve, a cork screw or a hook. In aparticular embodiment, the tip of the inner needle is turned inwardduring the delivery procedure to avoid the risk of inadvertent punctureof tissue. In another embodiment, the inner needle contains a portionthat has a different thickness or diameter than the rest of the innerneedle such as, for example, a tapered portion, whereby the inner needleis tapered from one thickness to another.

In an embodiment, the distal portion of the outer needle is moreflexible than the proximal portion of the outer needle.

In still another embodiment, the device includes a outer needle with ablunt distal end and a lumen axially disposed therethrough and a pumpfor introducing a high pressure jet spray through the lumen of the outerneedle.

In a further embodiment of the invention, the device has a outer needlewith a blunt distal end and an insulating material for insulating thelength of the proximal and intermediate portion, leaving the distal tipof the outer needle uninsulated. As an additional feature, the devicemay include unipolar electrodes or, alternatively, the device mayinclude bipolar electrodes.

In another aspect, the invention provides a method for puncturing theatrial septum of a patient's heart by accessing the right atrium via avessel. The method includes introducing into the right atrium atranseptal puncture device that includes a first outer needle with ablunt distal end and a lumen longitudinally disposed therethrough and asecond inner needle axially disposed in the lumen of the outer needle,the inner needle having a proximal portion, a distal portion, and anintermediate portion that is more flexible than the proximal portion orthe distal portion. The outer needle is contacted with the atrial septumand the inner needle is pushed through the septum in advance of theouter needle. A delivery sheath is then positioned using a standardcatheterization laboratory technique in the left atrium and thetranseptal puncture device is withdrawn from the patient's body.

In another aspect, the invention provides a method for puncturing theatrial septum of a patient's heart by accessing the right atrium via avessel. The method includes introducing into the right atrium atranseptal puncture device that includes a first, outer needle with ablunt distal end and a lumen longitudinally disposed therethrough and asecond, inner needle axially disposed in the lumen of the outer needle,the inner needle having a proximal portion and a distal portion, whereinthe distal portion is more flexible than the proximal portion. The outerneedle is first contacted with the atrial septum. The inner needle isthen pushed through the septum in advance of the outer needle. Adelivery sheath is positioned in the left atrium and the transeptalpuncture device is withdrawn from the patient's body.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference numbers generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention.

FIG. 1 is a plan view of a transeptal puncture device according to anillustrative embodiment of the invention.

FIG. 2 is a longitudinal plan view of the distal end of a transeptalpuncture device according to an illustrative embodiment of theinvention.

FIG. 3 is a cross sectional view of the distal end of a transeptalpuncture device taken along lines 3-3 in FIG. 2.

FIG. 4A is a longitudinal view of the distal end of an inner needle of atranseptal puncture device according to an illustrative embodiment ofthe invention in which the intermediate portion contains a waist.

FIG. 4B is an exploded view of the intermediate portion of FIG. 4A.

FIG. 5 is a longitudinal view of the distal end of an inner needle of atranseptal puncture device according to another illustrative embodimentof the invention in which the inner needle has a tapered intermediateportion.

FIG. 6 is a longitudinal view of the distal end of an inner needle of atranseptal puncture device according to another illustrative embodimentof the invention, in which the inner needle has an intermediate portion.

FIG. 7 is a longitudinal view of the distal end of an inner needle of atranseptal puncture device according to another illustrative embodimentof the invention in which the distal tip of the inner needle is bent.

FIG. 8 is a longitudinal view of the distal end of an inner needle of atranseptal puncture device according to another illustrative embodimentof the invention in which the distal end of the inner needle has a hook.

FIG. 9 a-9 g depicts the steps in an illustrative method for puncturingan atrial septum with an illustrative transeptal puncture deviceaccording to the invention.

FIG. 10 is a fragmented illustration of a septal puncture apparatusaccording to an illustrative embodiment of the invention.

FIG. 11 is a schematic side view of a portion of a septal punctureapparatus including a set of flexible members according to anillustrative embodiment of the invention.

FIG. 12A is a schematic side view of a portion of an embodiment of aseptal puncture apparatus including a set of flexible members partiallyextended from an elongate member.

FIG. 12B is a schematic side view of the flexible members of FIG. 12Afully extended from the opening in the elongate member.

FIG. 13 is a schematic side view of another embodiment of a set offlexible members according to the invention.

FIG. 14A is a schematic side view of an embodiment of a flexible memberaccording to the invention.

FIG. 14B is a schematic end-on view of the flexible member of FIG. 14A.

FIG. 15A is a schematic side view of an embodiment of a flexible memberaccording to the invention.

FIG. 15B is a schematic end-on view of the flexible member of FIG. 15A.

FIG. 16A is a schematic side view of an embodiment of a set of flexiblemembers, a cutting member, and an elongate member of a portion of aseptal puncture apparatus according to the invention.

FIG. 16B is an illustration of the set of flexible members and thecutting member extended out of the elongate member of FIG. 16A.

FIG. 17 is a partially broken-away view of a heart depicting a portionof a septal puncture apparatus, according to the invention, on a secondside of the septal wall.

FIG. 18A is a cross-sectional view of a septal wall of a heart depictinga set of flexible members located outside an opening in an end of anelongate member, according to an illustrative embodiment of theinvention.

FIG. 18B is a cross-sectional view of the flexible members of FIG. 19Ain which a portion of the flexible members is located in contact with afirst side of a septal wall and another portion of the flexible membersis located in proximity to a second side of the septal wall.

FIG. 18C is a cross-sectional view of the flexible members of FIGS. 19Aand 19B in which a cutting member is extended from a lumen in thedelivery member creating a hole through the septal wall.

FIG. 19 is a schematic side view of a flexible member, a cutting member,and an elongate member according to an illustrative embodiment of theinvention.

DETAILED DESCRIPTION OF THE INVENTION

The invention described herein relates to devices and methods forpuncturing the atrial septum via the percutaneous route for thetreatment of intracardiac defects such as, for example, patent foramenovale, intracardiac sources of emboli that may cause embolic stroke, anddefects related to cardiac disease.

In one aspect, the invention relates to a percutaneous device for makinga transeptal puncture in the atrial septum of the heart. FIG. 1 is aplan view of the transeptal puncture device according to an illustrativeembodiment of the invention. The illustrative percutaneous device 10includes a first, outer needle 12 including a lumen 13 axially disposedalong the long axis of the outer needle 12 and including a blunt distalend 17 having an opening 18. A second, inner needle 14 is axiallydisposed within the lumen of the outer needle 12. The outer needle 12provides structural support for the inner needle 14 and also functionsas a dilator of the hole created in the atrial wall by the inner needle14. The device 10 may further feature a transcutaneous intravascularsheath 22 through which the device 10 passes from outside the patient'sbody through a vessel, for example, the femoral vein, through theinferior vena cava to the right atrium, and a control handle 26 at thedistal end 27 of the sheath 22. The sheath and/or other components ofthe delivery system may be steerable by actuators (not shown) on thecontrol handle 26 to aid in delivering the device along the tortuousvascular path leading to the patient's right atrium. In certainembodiments, the distal end 17 of the outer needle 12 is tapered towardthe inner needle 14, and the distal end 27 of the sheath 22 is taperedtoward the outer needle 12.

In an embodiment, the outer needle 12 is similar in size to aBrockenbrough needle, e.g., with tip diameter of about 0.8 mm. Thepercutaneous device 10 also features a septal perforator, for example, asecond, inner needle 14. Alternatively, the septal perforator is a radiofrequency electrode (not shown) that is coupled to the outer needle 12,or is a high pressure jet spray (not shown) that is emitted from theopening 18 of the outer needle 12.

In an embodiment depicted in FIGS. 2 and 3, the inner needle 14 includesa sharp tip 25 at a distal end 15 of the inner needle 14. The innerneedle 14 is axially disposed within the lumen 13 of the outer needle12. The inner needle 14 is reciprocally and axially moveable in thelumen 13 of the outer needle 12. The inner needle 14 can be rotated aswell. The distal end 15 of the inner needle 14 is extendable through theopening 18 at the distal end 17 of the outer needle 12. The innerdiameter of the lumen 13 of the outer needle 12 typically approximatesthe outer diameter of the inner needle 14.

The outer needle 12 and the inner needle 14 are made from various metalssuch as, for example, nitinol, steel, or titanium, or alloys thereof orpolymers such as polyimide, PEBAX®, polyethylene,polytetrafluoroethylene (EPTFE), Fluorinatedethylenepropylene (FEP), andpolyurethane. In one embodiment, the inner needle 14 is solid toincrease its sharpness. Alternatively the inner needle 14 is hollow. Theuse of the outer needle 12 for introducing the inner needle 14 into thepatient's cardiac tissue is preferred. In another embodiment, a dilatorthat is made from material that provides sufficient support during thetranseptal puncture procedure is used and the outer needle 12 may not beneeded.

FIGS. 4A and 4B are a longitudinal view and an exploded view,respectively, of the distal end of an inner needle of a transeptalpuncture device according to another illustrative embodiment of theinvention. The illustrative inner needle 14 includes a waist 30 near thedistal end 15 of the inner needle 14. The waist 30 is positioned on anintermediate portion 16 of the inner needle 14 that is narrower indiameter than the portion of the inner needle 14 that is proximal to theintermediate portion 16 and the portion of the inner needle 14 that isdistal to the intermediate portion 16. The waist 30 is thereby moreflexible or bendable than the portions of the inner needle 14 that areproximal or distal to the waist 30. In one embodiment, the distalportion 15 is more flexible than the proximal portion 11 of the innerneedle 14. The intermediate portion 16 having waist 30 is positionedabout 5 mm to about 30 mm, preferably about 20 mm proximal to the distalend 15 of the inner needle 14. In an embodiment, the diameter of thewaist 30 ranges from about 0.1 mm to about 0.5 mm, e.g., if the waist iscomposed of a metal, while the diameter of the inner needle 14 proximalto the waist 30 ranges from about 0.5 mm to about 1.5 mm and thediameter of the inner needle 14 distal to the waist 30 ranges from about0.2 mm to about 1 mm. In another embodiment, the diameter of the waist30 ranges from about 0.1 to about 1 mm, e.g., if the waist is composedof a non-metal, such as, for example, a polymer, such as (PEBAX) orpolyurethane, a plastic, rubber, or any other polymer deemed suitable tothose skilled in the art. In that case, the diameter of the inner needle14 proximal to the waist 30 ranges from about 0.5 mm to about 3.0 mm andthe diameter of the inner needle 14 distal to the waist 30 ranges fromabout 0.2 mm to about 3.0 mm. For example, the diameter of the waist 30is about 0.2 mm, the diameter of the inner needle 14 proximal to thewaist 30 is about 1 mm and the diameter of the inner needle 14 distal tothe waist 30 is about 0.4 mm.

FIG. 5 is a longitudinal view of the distal end of an inner needle of atranseptal puncture device according to another illustrative embodimentof the invention. In one embodiment, the inner needle 14 diameter islarger (e.g., 1 mm larger) at the proximal end of the inner needle 14than the distal end 17. Alternatively, the inner needle 14 diameter islarger throughout the length of the inner needle 14 except for the mostdistal about 20 mm of the distal end 15. In one embodiment, the innerneedle 14 contains a portion 31 at the distal end 15 that is tapered orthe diameter of the inner needle 14 is gradually stepped down, forexample, to a diameter of about 0.1 to about 0.25 mm, preferably about0.2 mm, at a point “A” about 10 mm to about 20 mm proximal to the tip 25of the inner needle 14. In an embodiment, the diameter of the innerneedle 14 from the tip 25 to the point “A” is uniform. In a particularembodiment, the distal about 10 mm of the inner needle 14 adjacent tothe tip 25 has a diameter of about 0.2 mm. According to this embodimentof the invention, the distal end 15 of the inner needle 14 is thinnerand therefore is more flexible than the proximal portion 11 of the innerneedle 14. In another embodiment the tapered or step-down portion 31 canextend to the tip 25 of the inner needle 14 and can be about 5 mm toabout 30 mm long.

FIG. 6 is a longitudinal view of the distal end of an inner needle of atranseptal puncture device according to another illustrative embodimentof the invention. At a position about 5 mm to about 30 mm, preferablyabout 20 mm from the distal end 15, the inner needle 14 includes anintermediate portion 16 manufactured from, or coated with, a material ortreated such that the intermediate portion 16 is more likely to bendthan the portions of the inner needle 14 that are proximal 11 and distal15 to the intermediate portion 16. For example, if the inner needle 14is composed of nitinol, the intermediate portion 16 may be annealed at500 degrees Centigrade for 10 minutes to relieve stress in otherwisesuperelastic nitinol wire in an as drawn condition. Alternatively, theintermediate portion 16 may be made from a softer material than theproximal portion 11 and distal portion 15 of the inner needle 14. Forexample, the material of the intermediate portion 16 may be a polymerwhile the proximal portion 11 and distal portion 15 on the inner needle14 are made from, for example, a rigid metal or, alternatively, a nickeltitanium alloy such as nitinol. The intermediate portion 16 may bewelded to, crimped or attached by adhesives to the proximal portion 11and distal portion 15 of the inner needle 14. In one embodiment, theintermediate portion 16 is about 0.5 mm to about 30 mm, preferably about2 mm in length. Alternatively, geometric modification may make theintermediate portion 16 more flexible, for example, by the introductionof slits, grooves, cut-aways, notches, dimples, or other modificationthat thins portions of the wall of the intermediate portion 16.

In another embodiment (not shown), the distal, the proximal, and/or theintermediate portion (if present) of the inner needle 14 is flexible.

FIG. 7 is a longitudinal view of the distal end of an inner needle of atranseptal puncture device according to another illustrative embodimentof the invention. The distal end 15 of the illustrative inner needle 14may be straight (e.g., 0 degrees) or is bent at an angle ranging fromabout >0 degrees to about 270 degrees, preferably about 180 degreesrelative to the long axis of the inner needle 14.

Alternatively, referring to FIG. 8, when the distal end 15 of the innerneedle 14 is not constrained within the lumen 13 of the outer needle 12,the distal end 15 has an essentially non-traumatic conformation, such asa helical, curved, cork screw, or hook shape. For example, the diameter“B” of the loop that forms the hook 32 can be between about 5 mm andabout 30 mm, preferably about 10 mm. When the distal end 15 is enclosedwithin the lumen 13 of the outer needle 12, the entire length of theinner needle 14 is substantially straight and parallels the long axis ofthe outer needle 12.

In an alternative embodiment of the transeptal puncture device, theinner needle is replaced by a pulsating high pressure saline jet (orother suitable fluid) (not shown) generated by a pump. The jet spray isdirected to the atrial septum from the distal end of the blunt, outerneedle according to the invention and incises the tissue. The outerneedle is then gradually advanced through the incision. Because theincision is made gradually and slowly, the method is safer than thecurrently used methods, for example, because there is a reduced risk oftrauma and/or bleeding.

In yet another embodiment of the transeptal puncture device, the blunt,outer needle is replaced by a radio frequency (RF) apparatus (notshown). The outer needle according to the invention is insulated exceptfor the outer needle tip. The alternating current travels down the outerneedle. Preferably, unipolar electrodes can be used for the outer needlewith grounding pads typically placed on the patient's thighs.Alternatively, a bipolar electrode system can be employed as well. Theapplication of RF to the outer needle increases the tissue temperaturearound the outer needle tip to over 100 degrees C. Mechanical cohesionin the tissue is diminished and allows the outer needle to be advancedas pressure is applied to the tissue by the outer needle tip. Any othermethod producing heat (e.g., such as electrical resistance, laser, orultrasound) can be potentially used instead of RF. As with the salinejet described above, the incision is created slowly therefore the riskof accidental puncture of tissue that is not targeted for incision isminimal.

In another aspect, the invention provides a method using a percutaneousapproach for puncturing the atrial septum of a patient to treat, forexample, patent foramen ovale or to gain access to the left atrium toablate the left atrial appendage. FIGS. 9A-9E depict the steps of anillustrative method for puncturing an atrial septum with the transeptalpuncture device according to the invention. The illustrative methodincludes the step of introducing an intravascular sheath 22 in a vesselto access the lumen of the right atrium 24. In an embodiment, the sheath22 is tapered to enhance advancement of the sheath 22 though the atrialseptum 26. Referring to FIG. 9A, after the sheath 22 is properlypositioned in the right atrium 24, the outer needle 12 of the transeptaldevice 10 is advanced distally toward the atrial septum 26 andpositioned against septum primum 26 a at the puncture site. The bluntdistal end 17 of the outer needle 12 is then pushed against septumprimum 26 a until some tenting of the atrial septum 26 is visible. Thetenting should be sufficient to correctly identify the puncture site inthe septum primum 26 a. Alternatively, visualization techniques such as,three-dimensional echocardiogram or magnetic resonance imaging can beused that may work without tenting. Some amount of tenting also assistswith the puncture itself.

Referring to FIG. 9B, once the outer needle 12 is positioned, the innerneedle 14 is advanced relative to the outer needle 12 through the septum26. At its most distal position, about 10 mm of the inner needle 14should extend from the distal end 17 of the outer needle 12.Alternatively, the most distal position could be about 30 mm, if thedistal portion 15 of the inner needle 14 had a hook shape, as is shownin FIG. 8. In an embodiment, the transition from the hook portion to thestraight portion of the inner needle 14 is exposed. The outer needle 12follows the path of the inner needle 14 through the septum 26. Becauseof the fine diameter, extreme sharpness, and the added stiffnessprovided by the outer needle 12, the inner needle 14 can be initiallyadvanced into the septum 26. The motion of the inner needle 14 may beforward, vibrating, reciprocating, linear, or rotational, for example.In one embodiment, movement of the inner needle 14 is accomplishedmanually. Alternatively, movement of the inner needle 14 may beautomated and therefore require additional controls such as aspring-loaded needle to be attached to the delivery system componentssuch as the sheath 22. Such devices of the invention are easier for thedoctor to manipulate and safer for the patient.

Referring now to FIG. 9C, once the distal end 15 of the inner needle 14is positioned within the septum 26, the tissue provides support to theexposed part of the inner needle 14 until the whole tip of the innerneedle 14 is delivered into the left atrium 28. Referring to FIG. 9D,the outer needle 12 is advanced and positioned in the left atrium 28.Referring to FIG. 9E, standard catheterization laboratory procedures areutilized to place the sheath 22 within the left atrium 28. Once thesheath 22 is in the left atrium 28, the other components of the device,for example, the inner needle 14 and the outer needle 12, can becompletely removed from the sheath 22 and the sheath 22 can be used todeliver implants, for example, such as an atrial occluder for thetreatment of a patent foramen ovale, sutures, or other intracardiactherapeutic devices. For example, referring to FIG. 9F, one half of anoccluder 30 is released from the sheath 22 and positioned in the leftatrium 28. Referring to FIG. 9G, the sheath 22 is then withdrawn intothe right atrium 24 and the other half of the occluder 30 is releasedand positioned in the right atrium 24. In an embodiment, the innerneedle 14 is left behind, traversing the puncture site, and acts tomaintain the puncture site as well as to act as a guidewire (e.g., andthe other outer needle 12 is withdrawn). In another embodiment, theinner needle 14 is withdrawn, e.g., into the outer needle 12.

The method for transeptal puncture using the transeptal device describedherein is advantageous over conventional methods. For example, whenusing the devices and methods of the invention inadvertent contact ofthe inner needle 14 with the left atrial free wall (not shown)immediately after the septum 26 is punctured does not result in damageto or perforation of the left atrial free wall because the distal end 15of the inner needle 14 is very flexible, as illustrated, for example, inFIG. 4 and corresponding text, or has an alternative tip 25, asillustrated, for example, in FIG. 8 and corresponding text, when fullyextended from the distal opening 18 of the outer needle 12. When thedistal end 15 of the inner needle 14 contacts the left atrial free wall,the distal end 15 of the inner needle 14 harmlessly bends rather thanperforates the left atrial free wall. In one embodiment, the distal end15 of the inner needle 14 bends because of the enhanced flexibility ofthe inner needle 14 at the intermediate portion 16, as described abovein connection with FIGS. 4-8, between the proximal portion 11 and distalportion 15 of the inner needle 14. In an embodiment, perforation of theleft atrial wall is avoided by modifying the shape of the inner needle14 to form, for example, a hook or a bend.

Another advantage of the transeptal puncture devices described herein isthe ability of the device to puncture through thick septum such asseptum secundum. The transeptal puncture devices according to theinvention can be used for remote suturing of a PFO or other defects thatmay be accessed percutaneously.

The transeptal puncture device according to the invention can also beused with various atrial septal defect locators such as those describedin U.S. Ser. No. 10/660,444. For example, the locator may stabilize(e.g., constrain) the motion of the septa during insertion of the innerneedle. Generally, a locator system includes a plurality of flexiblemembers, at least one flexible member positionable on a side of thetissue opposite to another flexible member.

FIG. 10 illustrates a septal puncture apparatus 100 including threeflexible members 142 a, 142 b, and 142 c (generally 142) coupled to adelivery member 120 for applying, e.g., a pressure or force to a regionin a body by pushing, pulling, or restraining the tissue, therebystabilizing the tissue. The flexible members 142 a, 142 b, and 142 c maybe hexagonal in shape and coupled to a distal end 124 of the deliverymember 120, thereby forming, generally, a planar array 150. The deliverymember 120 is slideably receivable within a lumen 110 of the elongatemember 104. Instruments, e.g., the delivery member 120 and a cuttingmember 300 (e.g., a member that perforate the tissue, which cancomprise, referring to FIG. 1, an inner needle 14 and/or an outer needle12, for example), are slideably receivable in the lumen 110 of theelongate member 104. In this embodiment, the cutting member 300 isslideably receivable in a lumen 308 of the delivery member 120 andextends distally or withdraws proximally from an opening 312 at thedistal end 124 of the delivery member 120.

FIG. 10 also illustrates an exemplary interface 130 that permitscontrollers, for example, a set of apparatus controllers 134 and 138 tocommunicate with the elongate member 104 and the delivery member 120,respectively. The exemplary controllers 134 and 138 extend, retract, orotherwise manipulate, e.g., the elongate member 104 and the deliverymember 120, respectively. A single controller, could, alternatively,control all functions and operations of the tissue puncture apparatus100 and the instruments disposed therein.

By way of example, the elongate member 104 and the delivery member 120are flexible tubes fabricated from a biocompatible material, e.g.,polyethylene, polyether-amide block co-polymer (PEBAX™), polyurethane,or fluorinated ethylene propylene.

By way of example, the flexible members 142 are manufactured usingnickel-titanium material, such as Nitinol™ (Nitinol Devices andComponents, Freemont, Calif.), or other shape memory alloy materials.The nickel-titanium wire, when properly manufactured, exhibits elasticproperties for the wire to be manipulated (e.g., bent) by an operatorand then returned to, substantially, the same shape the wire possessedprior to it being manipulated.

Alternatively, FIG. 11 illustrates a portion of a septal punctureapparatus 100 including exemplary flexible members 142′a and 142′b,which each include a leg such as a wire having a first end 204′a and204′b, respectively, joined to the distal end 124 of the delivery member120. Each of the flexible members 142′a and 142′b also have a seconddistal end 202′a and 202′b, respectively, that is free, i.e., not joinedto any other structure of the septal puncture apparatus 100. Thelongitudinal axis of the flexible members 142′a and 142′b are orientedsubstantially parallel to the elongate member 104 when the flexiblemembers 142′a and 142′b are located within the lumen 110 of the elongatemember 104. The flexible members 142′a and 142′b have a first portion272 a and 272 b, respectively and a second portion 270 a and 270 b,respectively. The flexible members 142′a and 142′b are disposed withinthe lumen 110 in a contracted position such that the second ends 202′aand 202′b are directed distally towards the opening 112 in the distalend 106 of the elongate member 104. The flexible members 142′a and 142′bare freed from the confines of the lumen 110 by moving the flexiblemembers 142′a and 142′b between the contracted position illustrated, forexample, in FIG. 11 and an extended position, such as the extendedposition depicted in FIG. 12B. After insertion into the lumen 110 of theelongate member 104, the flexible members 142′a and 142′b apply a forceto an inner surface 210 of the elongate member 104 in a first location230 a and 230 b, respectively, on the inner surface 210 of the lumen 110that the flexible members 142′a and 142′b contact.

Referring now to FIG. 12A, as the delivery member 120 is extended out ofthe opening 112 of the elongate member 104, the second ends 202′a and202′b of the flexible members 142′a and 142′b, respectively, undergo anarticulation and point, generally, in a proximal direction toward thehandle (not shown). Referring now to FIG. 12B, the elongated deliverymember 120 is further extended distally along the lengthwise dimension(in the positive direction along the X-axis) of the lumen 110 until thedistal end 124 of the delivery member 120 emerges from the opening 112of the elongate member 104. The second ends 202′a and 202′b of theexemplary preshaped flexible members 142′a and 142′b, respectively,undergo an additional articulation and as a result point, generally,towards one another. In this extended position, each of the flexiblemembers 142′a and 142′b is substantially planar in shape.

Alternatively, the second ends, for example, the second ends 202′a and202′b, may have a different diameter than other locations along thelength of the flexible elastic members 142′a and 142′b. By way ofexample, an operator may select an apparatus having flexible membersthat have second ends 202′a and 202′b having a larger diameter to, forexample, reduce trauma to tissue the second ends 202′a and 202′b contactduring use. Alternatively, the second ends 202′a and 202′b may have aball shaped tip.

FIG. 13 depicts exemplary flexible members 142″a and 142″b that includea first wire loop section 220 a and a second loop section 220 b,respectively. The tip 406 a and 406 b of the loop sections 220 a and 220b, respectively, point, generally, towards one another and towards thedelivery member 120. Loop sections 220 a and 220 b may, alternatively,be oriented in a variety of directions (e.g., away from the deliverymember 120 or at a 45 degree angle away from the delivery member 120).

Referring now to FIGS. 14A and 14B, a septal puncture apparatus 100includes a single flexible member 142′″ that has a middle section 540located, generally, intermediate the first end 206 and the second end208 of the flexible member 142′″. The flexible member 142′″ therebyforms a closed loop. In this embodiment, the flexible member 142′″ isconfigured so the middle section 540 is located, generally in the centerof a plane defined by the flexible member 142′″ as illustrated by theend-on view of FIG. 14B. In this configuration, the middle section 540of the flexible member 142′″ aids with stiffening the flexible member142′″, which minimizes bending when, for example, the flexible member142′″ is used by an operator to apply forces to a tissue, e.g., theatrial septum. In this configuration, the flexible member 142 forms aclosed loop that is sized and shaped, for example, to contact a firstand second side of a tissue.

Referring now to FIGS. 15A and 15B, the flexible elastic member 142″″ isa coil and has a spiral shape. By way of example, in use, a portion 1410of the flexible member 142″″ can be located on a first side of a tissueand a portion 1420 of the flexible member 142″″ can be located on asecond side of a tissue. For example, the flexible member 142″″ can bescrewed through a tunnel or a hole, such as a defect in the atrialseptum. Alternatively, the distal end 124 of the delivery member 120 maybe located axially through, for example, a hole in a tissue such thatthe flexible member 142″″ may be withdrawn partially through the hole bya rotational (screw-like) motion of the delivery member 120 therebylocating the portion 1410 of the flexible member 142″″ on a first sideof the tissue and the portion 1420 of the flexible member 142″″ on asecond side of a tissue.

Referring to FIG. 16A, the delivery member 120 is translated axiallyalong the lengthwise dimension of the lumen 110 until the distal end 124of the delivery member 120 emerges from an opening 112 in the elongatemember 104 and the flexible members 142 a, 142 b, and 142 c transitionfrom the contracted first position 330 shown in FIG. 16A to a secondextended position 340 shown in FIG. 16B. The exemplary flexible members142 a, 142 b, and 142 c expand to assume, for example, substantiallyhexagonal shapes upon emerging from the opening 112 in the elongatemember 104 and expanding. The extended flexible members 142 a, 142 b,and 142 c are substantially planar. The plane defines a plurality ofaxes that lie in the plane and the plurality of axes are non-parallel to(i.e., biased relative to) the elongate member 104. An angle 344 definedby at least one of the plurality of axes of the plane of the flexiblemembers 142 a, 142 b, and 142 c and the longitudinal axis of theelongate member 104 is typically specified (e.g., by an operator) suchthat the flexible members 142 a, 142 b, and 142 c are flush with tissuesurface and are capable of applying a force across a large tissue area.For example, the angle 344 might be chosen to ensure the flexiblemembers 142 a, 142 b, and 142 c conform to the shape of a tissue surfaceabutting the flexible members 142 a, 142 b, and 142 c. If the force isapplied, e.g., across a large tissue area the movement of the tissue inany location across the tissue area will be minimized. The flexiblemembers 142 a, 142 b, and 142 c could, alternatively, be of any shape(e.g., polygonal, circular, or ellipsoidal) or of any quantity (e.g.,one, two, or five) where the shape and/or quantity of the flexiblemembers 142 a, 142 b, and 142 c are typically selected to distribute asmuch force as possible while still being able to fit within the lumen110 of the elongate member 104 and emerge from or retract into the lumen110.

When the flexible members 142 a, 142 b, 142 c are extended in the secondexpanded position 340 upon emerging from the opening 112, the exemplarycutting member 300 extends axially in the lumen 308 of the deliverymember 120 until a cutting tip 304 of the cutting member 300 emergesfrom the opening 312 in the distal end 124 of the delivery member 120.The tip 304 of the cutting member 300 cuts the tissue in close proximityto the opening 312 of the delivery member 120.

Referring now to FIG. 17, an operator introduces an elongate member 104into the right atrium 748 of a heart 742 through the descending venacava 750. The elongate member 104 is advanced distally until the distalend 106 of the elongate member 104 passes through a defect 620 (forexample, a patent foramen ovale) in the septum 740. The distal end 106of the elongate member 104 is shown at an angle 770 of about 45 degreesrelative to the longitudinal axis of the elongate member 104 due to abend 760 in the distal end of 106 of the elongate member 104. The bend760 in the elongate member 104 may be mechanically pre-formed orpre-bent at the angle 770 between about 0 degrees and about 180 degreesprior to insertion of the elongate member into the body. The bend 760could, alternatively, be accomplished by heating a nickel-titaniummaterial or other shape memory alloy located within the distal end 106of the elongate member 104.

The septal puncture apparatus shown in FIGS. 18A, 18B, and 18C includestwo flexible members 142′a and 142′b coupled to the distal end 124 ofthe delivery member 120. The flexible members 142′a and 142′b areinitially located within the lumen 110 of the elongate member 104. Anoperator initially guides the distal end of 106 of the elongate member104 through the defect (hole) 620 such that the distal end 106 islocated on a second side 820 (in the left atria of the heart) of theseptum secundum 600 and septum primum 610. Now referring to FIG. 18A,the operator then extends the flexible members 142′a and 142′b asdescribed herein with respect to, for example, FIGS. 12A and 12B.

With continued reference to FIG. 18A, the elongate member 104 isretracted proximally until the distal end 106 of the elongate member 104passes back through the defect 620 and is positioned on the first side810 of the septum 740.

The delivery member 120 is then retracted proximally so the secondportions 270 a and 270 b of the flexible members 142′a and 142′b and thedistal end 124 of the delivery member 120 are in close proximity to thedefect 620, the septum primum 610, and the septum secundum 600 on thesecond side 820 of the septum 740.

Now referring to FIG. 18B, as the delivery member 120 is furtherretracted proximally such that the distal end 124 of the delivery member120 is withdrawn through the defect 620 until it is in contact with orin close proximity to the first surface 880 of the septum primum 610 onthe first side 810 of the septum primum 610. The second portions 270 aand 270 b of the flexible members 142′a and 142′b are positioned,generally non-parallel to the longitudinal axis of the elongate member104 and are in physical contact with at least the second surface 870 ofthe septum primum 610 on the second side 820 of the septum primum 610and also partially located within the defect 620 in the septum 740. Thefirst portions 272 a and 272 b of the flexible members 142′a and 142′bare located on the first side 810 of the septum 740. Accordingly, theflexible members 142′a and 142′b are sized and shaped for contact withthe first side 810 and the second side 820 of the septum 740. Theflexible members 142′a and 142′b are thus capable of limiting movementof the septum primum 610. Now referring to FIG. 18C, the cutting member300 is extended from the opening 312 in the distal end 124 of thedelivery member 120. The cutting tip 304 of the cutting member 300introduces a hole 1005 (tissue opening) through the septum primum 610.

Referring now to FIG. 19, an exemplary flexible member 142 is attachedto the distal end 124 of the delivery member 120, which extends from theopening 112 in the distal end 106 of the elongate member 104. Thedelivery member 120 and the elongate member 142 are located on the firstside 810 of the septum secundum 600. The distal end 124 of the deliverymember 120 is located in close proximity to the tissue surface of theseptum secundum 600 on the first side 810 of the septum secundum 600.The flexible member 142 extends through the hole 620 between the septumprimum 610 and the septum secundum 600 from the first side 810 to thesecond side 820. The first side 810 of the septum primum 610 opposes thesecond side 820 of the septum primum 610. The flexible member 142 ispositioned so that the second end 202 and second portion 270 of theflexible member 142 are located on the second side 820 of the septumsecundum 600 and the first portion 272 of the flexible member 142 islocated on the first side 810 of the septum secundum 600. In thisconfiguration, the flexible member 142 is thus capable of limitingmovement of the septum secundum 600. In this embodiment only the septumsecundum 600 is secured to limit movement. In alternative embodiments,however, the septum secundum 600 and/or the septum primum 610 may besecured to limit movement.

Additionally, it should be noted that Applicants intend any operableembodiments existing between the devices, methods and applicationsthereof disclosed in the illustrative embodiments described above to beconsidered within the scope of the inventions disclosed herein and, assuch, claimable subject matter.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein. Scope of theinvention is thus indicated by the appended claims rather than by theforegoing description, and all changes that come within the meaning andrange of equivalency of the claims are intended to be embraced therein.

INCORPORATION BY REFERENCE

All publications and patent documents cited in this application areincorporated by reference in their entirety for all purposes to the sameextent as if the contents of each individual publication or patentdocument was incorporated herein.

1-7. (canceled)
 8. The device of claim 48, wherein the intermediateportion has a longitudinal length ranging from about 0.5 mm to about 30mm. 9-16. (canceled)
 17. The device of claim 48 wherein the distalportion of the inner needle comprises a distal tip portion that deviatesfrom the linear path of the needle when not constrained within the lumenof the outer needle. 18-22. (canceled)
 23. The device of claim 48,wherein the first material is nitinol. 24-47. (canceled)
 48. A devicefor puncturing the atrial septum of a patient, comprising: an outerneedle comprising a blunt distal end and a lumen longitudinally disposedsubstantially therethrough; a solid inner needle axially disposed in thelumen of the outer needle and moveable beyond the distal end of theouter needle, the solid inner needle comprised substantially of a firstmaterial and comprising a proximal portion, an intermediate portion, anda distal portion, wherein the intermediate portion is substantiallystraight and is more flexible than the distal portion and the distalportion is more flexible than the proximal portion, and wherein thedistal portion generally increases in flexibility from a proximal end toa distal end and includes a sharp tip configured to pierce the atrialseptum; and wherein the intermediate portion includes a second materialthat is different from the first material.
 49. The device of claim 48,wherein the second material includes a polymer. 50-51. (canceled) 52.The device of claim 48, wherein the intermediate portion includes atleast one of a slit, a groove, a cut-away, a notch, and a dimple. 53.The device of claim 48, wherein the intermediate portion has across-sectional area that is smaller than the cross-sectional area ofthe proximal section.
 54. The device of claim 17, wherein the distalportion, when residing outside the outer needle, is capable for forminga shape selected from the group consisting of a helix, a curve, a corkscrew, and a hook.
 55. The device of claim 48, wherein the distalportion has sufficient stiffness to penetrate the atrial septum when thedistal portion substantially resides within the outer needle and hasinsufficient stiffness to penetrate cardiac tissue when the distalportion substantially resides outside the outer needle.
 56. The deviceof claim 48, wherein the distal portion has a longitudinal lengthranging from about 5 mm to about 30 mm.
 57. The device of claim 56,wherein the distal portion has a longitudinal length ranging from about10 mm to about 20 mm.
 58. (canceled)
 59. The device of claim 48, furtherincluding one or more flexible members configured to contact the atrialseptum, wherein at least one of the one or more flexible members isconfigured to reside within a lumen in a compressed state and configuredto reside in an expanded state when outside the lumen.
 60. The device ofclaim 59, wherein at least one of the flexible members includes a shapeselected from at least one of a hexagon, a curve, a loop, a planarsection, a coil, and a spiral.
 61. The device of claim 59, wherein atleast one of the flexible members is connected to at least one of theouter needle and the solid inner needle.
 62. The device of claim 59,wherein at least one of the flexible members is connected to an elongatemember, wherein the elongate member includes a lumen configured toreceive the outer needle.
 63. The device of claim 59, wherein at leastone of the flexible members includes nitinol.
 64. The device of claim59, wherein at least one of the flexible members is configured tocontact a first side and a second side of the atrial septum.
 65. Thedevice of claim 59, wherein at least one of the flexible members isconfigured to reside within a hole in the atrial septum. 66-67.(canceled)
 68. The device of claim 48, wherein the distal portion has agenerally conical shape that extends from the proximal end to the distalend of the distal portion.
 69. The device of claim 48, wherein theintermediate portion has a generally uniform cross-section along alongitudinal axis of the intermediate portion.
 70. (canceled)
 71. Thedevice of claim 48, wherein the device is moveable between a piercingconfiguration in which at least part of the distal portion of the solidneedle is located within the lumen of the outer needle and anon-piercing configuration wherein at least part of the intermediateportion is located outside the lumen of the outer needle. 72-80.(canceled)
 81. A device for puncturing the atrial septum of a patient,comprising: an outer needle comprising a blunt distal end and a lumenlongitudinally disposed substantially therethrough; and a solid innerneedle axially disposed in the lumen of the outer needle and moveablebeyond the distal end of the outer needle, the solid inner needlecomprised substantially of a single material and comprising: a proximalportion having a distal end; an intermediate portion having a proximalshoulder and a distal shoulder; and a distal portion having a proximalend abutting the distal shoulder and a sharp tip configured to piercethe atrial septum; wherein the flexibility of the intermediate portionfrom the proximal shoulder to the distal shoulder is greater than theflexibility of the proximal end of the distal portion and theflexibility of the distal portion is greater than the flexibility of theproximal portion, and wherein the distal portion includes a taperextending from the proximal end to the sharp tip.
 82. A device forpuncturing the atrial septum of a patient, comprising: an outer needlecomprising a blunt distal end and a lumen longitudinally disposedsubstantially therethrough; and a solid inner needle axially disposed inthe lumen of the outer needle and moveable beyond the distal end of theouter needle, the solid inner needle comprised substantially of a singlematerial and comprising: a proximal portion having a distal end; anintermediate portion having a proximal shoulder and a distal shoulder;and a distal portion having a proximal end abutting the distal shoulderand a sharp tip configured to pierce the atrial septum; wherein theflexibility of the intermediate portion from the proximal shoulder tothe distal shoulder is greater than the flexibility of the proximal endof the distal portion and the flexibility of the distal portion isgreater than the flexibility of the proximal portion, and wherein thedistal portion continuously increases in flexibility from the proximalend to the sharp tip.